Revance Provides Clinical Milestones and Financial Outlook for 2017
January 05, 2017
- Reports 2016 Unaudited Year-end Cash and Investments Balance -
- Three Clinical Trials Expected to Report Results in 2017 -
"As we enter 2017, we remain focused on leveraging our neurotoxin
platform and rapidly advancing our RT002 programs with three active
clinical trials that will yield key results before year end," said
RT002 INJECTABLE 2017 CLINICAL MILESTONES
Phase 3
Glabellar lines are the vertical lines that develop between the eyebrows as a result of repeated frowning, scowling, or merely focusing while listening or reading. As a person ages, the skin becomes less elastic and glabellar lines become more pronounced. In the fourth quarter of 2016, Revance initiated its Phase 3 program of RT002 injectable for the treatment of glabellar lines, comprised of two Phase 3 pivotal trials evaluating the efficacy, safety and duration of RT002, and a long-term safety trial. Revance plans to report results from both pivotal trials in the fourth quarter of 2017.
Phase 2 Trial for Treatment of Cervical Dystonia - Share Topline Results 1H 2017
Patients with cervical dystonia suffer from painful, embarrassing
twisting movements of the neck, often impairing their ability to work,
drive and perform activities of daily living. In
Phase 2 Trial for Treatment of Plantar Fasciitis - Report Phase 2 Results 2H 2017
The plantar fascia is the foot's shock absorber. Repeated pressure on this tissue, whether from sport activities, aging, or obesity, can result in plantar fasciitis, characterized by inflammation accompanied by sharp, constant pain in the heel that can become highly debilitating. Revance initiated a Phase 2 clinical trial of RT002 injectable for the treatment of plantar fasciitis in the fourth quarter of 2016 and continues to enroll patients. Topline results are expected in the second half of 2017.
FINANCIAL OUTLOOK FOR 2017
Revance expects cash burn for 2017 to be in the range of
About
Revance, a Silicon Valley-based biotechnology company, is committed to the advancement of remarkable science. The company is developing a portfolio of products for aesthetic medicine and underserved therapeutic specialties, including dermatology, orthopedics and neurology. Revance's science is based upon a proprietary peptide technology, which when combined with active drug molecules, may help address current unmet needs.
Revance's initial focus is on developing daxibotulinumtoxinA, the company's highly purified botulinum toxin, for a broad spectrum of aesthetic and therapeutic indications, including facial wrinkles and muscle movement disorders. The company's lead drug candidate, DaxibotulinumtoxinA for Injection (RT002), is currently in development for the treatment of glabellar lines, cervical dystonia and plantar fasciitis with the potential to be the first long-acting neurotoxin. The company holds worldwide rights for all indications of RT002 injectable and RT001 topical and the pharmaceutical uses of its proprietary peptide technology platform. More information on Revance may be found at www.revance.com.
"Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
Forward Looking Statements
This press release contains forward-looking statements, including
statements related to
Forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from our
expectations. These risks and uncertainties include, but are not limited
to: the outcome, cost, and timing of our product development activities
and clinical trials; the uncertain clinical development process,
including the risks that interim results are not indicative of final
results and that clinical trials may not have an effective design or
generate positive results; our ability to obtain and maintain regulatory
approval of our drug product candidates; our ability to obtain funding
for our operations; our plans to research, develop, and commercialize
our drug product candidates; our ability to achieve market acceptance of
our drug product candidates; unanticipated costs or delays in research,
development, and commercialization efforts; the applicability of
clinical study results to actual outcomes; the size and growth potential
of the markets for our drug product candidates; our ability to
successfully commercialize our drug product candidates and the timing of
commercialization activities; the rate and degree of market acceptance
of our drug product candidates; our ability to develop sales and
marketing capabilities; the accuracy of our estimates regarding
expenses, future revenues, capital requirements and needs for financing;
our ability to continue obtaining and maintaining intellectual property
protection for our drug product candidates; and other risks. Detailed
information regarding factors that may cause actual results to differ
materially from the results expressed or implied by statements in this
press release may be found in Revance's periodic filings with the
Use of Non-GAAP Financial Measures
Revance has presented certain non-GAAP financial measures in this release. This release and the reconciliation tables included herein include total non-GAAP operating expense and non-GAAP R&D expense, both of which exclude depreciation and stock-based compensation. Revance excludes depreciation costs and stock-based compensation expense because management believes the exclusion of these items is helpful for investors to evaluate Revance's recurring operational performance. Revance management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for or superior to GAAP results.
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Reconciliation of GAAP Operating Expense to Non-GAAP Operating
Expense |
||||||||||
| Fiscal Year | ||||||||||
| 2017 | ||||||||||
| Low | High | |||||||||
| Operating expense: | ||||||||||
| GAAP operating expense | $ | 108,000 | $ | 119,000 | ||||||
| Adjustments: | ||||||||||
| Stock-based compensation | (13,000 | ) | (15,000 | ) | ||||||
| Depreciation | (1,000 | ) | (2,000 | ) | ||||||
| Non-GAAP operating expense | $ | 94,000 | $ | 102,000 | ||||||
|
Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense |
||||||||||
| Fiscal Year | ||||||||||
| 2017 | ||||||||||
| Low | High | |||||||||
| R&D expense: | ||||||||||
| GAAP R&D expense | $ | 75,000 | $ | 83,000 | ||||||
| Adjustments: | ||||||||||
| Stock-based compensation | (5,000 | ) | (6,000 | ) | ||||||
| Depreciation | (1,000 | ) | (2,000 | ) | ||||||
| Non-GAAP R&D expense | $ | 69,000 | $ | 75,000 | ||||||
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or
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Media:
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